Acute Coronary Syndrome
Conditions
Keywords
STEMI, NSTEMI, Acute kidney injury, Renal function, Statin therapy
Brief summary
Registration of all ACS patients (STEMI and NSTEMI) admitted to the cardiology ward and scheduled for early invasive strategy. The aim is to evaluate the protective effects of early (on admission) high-dose high-potency statin therapy on early and mid-term cardiac and renal events in this subset of patients.
Detailed description
Statin-naive patients and those on statin therapy with ACS who are admitted to the cardiology ward of our public (National Health Service) hospital and are scheduled for early invasive strategy receive immediately on admission, always before angiographic procedure, high-dose statin therapy. Either atorvastatin 80 mg or rosuvastatin 40 mg is administered at the discretion of the physician. During hospitalization various pertinent cardiac and renal parameters, including hematological, angiographic, clinical data are registered in a dedicated database. Clinical follow-up and hematological analysis are done 1 month after discharge. A second follow-up, either clinical or by telephone, is done 1 year after discharge.
Interventions
None listed
Sponsors
Azienda USL 4 Prato
Centro Cardiopatici Toscani
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Acute coronary syndrome (ST elevation and non ST elevation) * Early invasive strategy
Exclusion criteria
* contraindication to statin therapy * refusal of consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Platelet aggregation profile | up to 1 month | Changes from baseline in platelet reactivity (Verify Now) |
| Inflammatory profile changes | up to 1 month | Changes from baseline in CRP values |
| Lipid profile changes | up to 1 month | Changes from baseline in cholesterol values |
| Platelet count | up to 1 month | Changes from baseline in platelet count |
| Platelet volume | up to 1 month | Changes from baseline in platelet volume |
| Acute renal function changes | Within 72 hours after hospital admission | Changes in creatinine and/or cystatine values |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major cardiovascular adverse events | up to 12 months | Death, myocardial infarction, stroke or coronary revascularization |
| Renal function changes | Changes from baseline at 1 month | glomerular filtration rate |
| Major adverse cardiovascular and renal adverse events | up to 1 month | Death, myocardial infarction, stroke, coronary revascularization or glomerular filtration rate reduction \> = 25% compared to baseline |
Other
| Measure | Time frame | Description |
|---|---|---|
| Impact of age and frailty profile on primary and secondary outcomes | Up to 1 month | Frailty evaluation (combination of FRAIL scale questionnaire and hand-grip strength measurement) |
Countries
Italy
Contacts
Primary ContactAnna Toso, MD
Backup ContactMario Leoncini, MD
Outcome results
None listed